Seclusion and restraint for people with serious mental

illnesses (Review)

Sailas EES, Fenton M

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2012, Issue 6
http://www.thecochranelibrary.com

Seclusion and restraint for people with serious mental illnesses (Review)
Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
NOTES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Seclusion and restraint for people with serious mental illnesses (Review) i
Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Review]

Seclusion and restraint for people with serious mental

illnesses

Eila ES Sailas1 , Mark Fenton2

1 National
reseearch and development centre for welfare and health, Helsinki, Finland. 2 Database of Uncertainties about the Effects of
Treatments (DUETs), National Institute for Health and Clinical Excellence, Manchester, UK

Contact address: Eila ES Sailas, National reseearch and development centre for welfare and health, PO Box 220, Helsinki, 00531,
Finland. Eila.Sailas@stakes.fi.

Editorial group: Cochrane Schizophrenia Group.

Publication status and date: Edited (no change to conclusions), published in Issue 6, 2012.
Review content assessed as up-to-date: 26 October 1999.

Citation: Sailas EES, Fenton M. Seclusion and restraint for people with serious mental illnesses. Cochrane Database of Systematic
Reviews 2000, Issue 1. Art. No.: CD001163. DOI: 10.1002/14651858.CD001163.

Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT

Background

Seclusion and restraint are interventions used in the treatment and management of disruptive and violent behaviours in psychiatry. The
use of seclusion varies widely across institutions. The literature does offer numerous suggestions for interventions to reduce or prevent
aggression.

Objectives

1. To estimate the effects of seclusion and restraint compared to the alternatives for those with serious mental illnesses.

2. To estimate the effects of strategies to prevent seclusion and restraint in those with serious mental illnesses.

Search methods

Electronic searches of The Cochrane Controlled Trials Register (Issue 1, 1999) and The Cochrane Schizophrenia Groups Register
(January 1999) were supplemented with additional searches of Biological Abstracts (1989-1999), CINAHL (1982-1999), EMbase
(1980-1999), MEDLINE (1966-1999), MEDIC (1979-1999), PsycLIT (1974-1999), Sociofile (1974-1999), SPRI & SWEMED
(1982-1999), Social Sciences Citation Index (1996-1999), and WILP (1983-1999). In addition, trials were sought by hand searching
the reference lists of all identified studies and conference abstracts and contacting the first author of each relevant study.

We updated this search 10 May 2012 and added the results to the awaiting classification section of the review.

Selection criteria

Randomised controlled trials were included if they focused on the use (i) of restraint or seclusion; or (ii) of strategies designed to reduce
the need for restraint or seclusion in the treatment of serious mental illness.

Data collection and analysis

Studies were reliably selected, quality rated and data extracted. For dichotomous data relative risks (RR) with 95% confidence intervals
(CI) were estimated. Normal continuous data were summated using the weighted mean difference (WMD).
Seclusion and restraint for people with serious mental illnesses (Review) 1
Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Main results

1. Effect of seclusion and restraint

The search strategy yielded 2155 citations. Of these, the full articles for 35 studies were obtained. No studies met minimum inclusion
criteria and no data were synthesised. Most of the 24 excluded studies focused upon the restraint of elderly, confused people and
preventing them from wandering or falling.

2. Prevention of seclusion and restraint

Work ongoing.

3. Update search 2012: the 2 new citations in the awaiting classification section of the review may alter the results and conclusions of
the review once assessed.

Authors conclusions

No controlled studies exist that evaluate the value of seclusion or restraint in those with serious mental illness. There are reports of
serious adverse effects for these techniques in qualitative reviews. Alternative ways of dealing with unwanted or harmful behaviours
need to be developed. Continuing use of seclusion or restraint must therefore be questioned from within well-designed and reported
randomised trials that are generalisable to routine practice.

PLAIN LANGUAGE SUMMARY

Seclusion and restraint for people with serious mental illnesses

Synopsis pending.

BACKGROUND
Seclusion and restraint are interventions used in the treatment and
management of disruptive and violent behaviours in psychiatry
(APA 1985). Seclusion is the placement and retention of an inpa-
tient in a bare room for containing a clinical situation that may
result in a state of emergency. Restraint involves measures designed
to confine a patients bodily movements (Gutheil 1995). Seclusion
and restraint are suggested to prevent injury and reduce agitation,
but the use of seclusion and restraint can have substantial delete-
rious physical and more often psychological effects on both the
patient and the staff (Fisher 1994). It is claimed that seclusion and
restraint reduce agitation and prevent injury (Gerlock 1983).
The theoretical foundations of seclusion, much debated in the lit-
erature, are based on whether it is a valid therapeutic interven-
tion in itself, merely a method of containment of a psychiatric
emergency or a form of punishment (Mason 1993). The review-
ers know of no literature discussing differences between seclusion
and restraint. The effect of these interventions on the frequency
of aggressive incidents is not known (Nijman 1997).
The use of seclusion varies widely across institutions from 0 to 66%
Seclusion and restraint for people with serious mental illnesses (Review)
Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Brown 1992). In a single group of state psychiatric hospitals, all
operating the same policies and procedures, considerable variation
in the rates of seclusion and restraint were found (Way 1990).
Hospitals with high use had a rate more than three times greater
than hospitals with low usage. The rate of seclusion and restraint
in the 23 hospitals ranged from 0.4 to 9.4% of patients. Only some
of the differences between hospitals could be explained by patient
characteristics and a large facility effect was found (Way 1990).
The least restrictive principle is inconsistently used, and creative
alternatives to confinement are not always employed (Aschen
1995). There are only very few studies that calculate the relative
risk of seclusion and restraint in different populations (Hyer
1994) and the characteristics of secluded or restraint patients also
differ widely from one study to another (Swett 1994, Walsh 1995).
In addition, there are reports of patients treated effectively with no
use or very little use of restraint and seclusion in many psychiatric
settings (Ray 1995).
In some follow-up studies, despite political changes and changes
in the size and mission of hospitals, rates of seclusion and restraint
have not changed (Crenshaw 1997, Salib 1998). This has been
2
used as evidence to show that seclusion of some disturbed patients
will inevitably continue to be used. Further it has been suggested
that when a patient cannot co-operate and is at a risk of being
dangerous to himself or others seclusion may be the safest and most
dignified intervention, especially if there are concerns arising from
the patients medical or psychiatric history (Farnham 1997). Yet,
few other forms of treatment which are applied to patients with
various psychiatric diagnoses are so lacking in basic information
about their proper use and efficacy (Angold 1989).
Violent incidents in psychiatric settings are frequent, serious, un-
derreported and may be an increasing problem (Shah 1991). They
do not happen at random and warning signs often exist. These
signs may, however, be difficult to identify and interpret (Owen
1998). Three means of controlling violence are verbal de-escala-
tion, medication and/or physical restraint (Tardiff 1992). The lit-
erature does offer numerous suggestions for aggression-reducing
and preventing interventions. These include for instance sugges-
tions for medication, staff training programs, approaches devel-
oped to de-escalate threatening situations, behavioral modifica-
tions methods and others (Chow 1996, Essock 1996, McDonnell
1996, Whittington 1996, Kalogjera 1989, Phillips 1995). Rela-
tively little is known about the effects of these interventions on
the frequency of aggressive incidents (Nijman 1997).
OBJECTIVES
1. To estimate the effects of seclusion and restraint measured
against standard care or other alternative interventions for treat-
ing people who are violent or a serious danger to themselves or
others. It was also proposed to identify any effects of the different
techniques for staff.
2. To estimate the effects of strategies used to prevent the use of
seclusion and restraint of mentally ill people.
METHODS
Criteria for considering studies for this review
Types of studies
1. Effects of seclusion and restraint
All relevant randomised controlled trials of seclusion and restraint.
2. Prevention of seclusion and restraint
All relevant randomised controlled trials of strategies used to re-
duce the need for seclusion or restraint.
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Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Types of participants
1. Effects of seclusion and restraint
People with serious or chronic mental illness. People with demen-
tia, or people who were likely to be suffering from dementia or
cognitive impairment caused by illness other than psychotic dis-
orders, were, where possible, excluded from this part of the review.
Trials primarily focusing on restraining older people to prevent
them from wandering were also excluded.
2. Prevention of seclusion and restraint
Anybody who is the focus of a strategy with the primary focus
of prevention of seclusion and restraint. As such strategies may
not be patient focused, the following participants are included: (i)
staff; (ii) organisations; (iii) people with serious or chronic mental
illness.
Interventions that aim to reduce the use of seclusion or restraint
in the treatment of those whose main problems are learning diffi-
culties, dementia, or drug and alcohol abuse were excluded.
Types of interventions
1. Effects of seclusion and restraint measured against standard
care or other alternative interventions
a. Seclusion: containment of the patient alone in a room or other
enclosed area from which the patient has no means of freely leaving
the area. This does not include the use of locked wards.
b. Restraint: restricting the patients ability to move by using dif-
ferent devices designed for this purpose or holding the patient
down by physical force.
c. Standard care: care delivered under current custom and practice
of the unit where the interventions were being compared, not
including seclusion or restraint.
2. Prevention of seclusion and restraint
a. Educational strategies;
b. behavioural strategies;
c. any alternative response to seclusion or restraint;
d. changes in policy;
e. medication;
f. administrative measures; or
g. standard care: defined as care delivered under current custom
and practice of the unit where the interventions were being com-
pared.
Types of outcome measures
Outcomes were grouped according to time periods: immediate
(up to one week), short term (from one week to less than one
month), medium term (1-6 months) and long term (more than
six months).
Primary outcomes
Effects of seclusion and restraint
3
The outcome measures used in each trial were all described. 5.2. Carer satisfaction
The primary outcomes of interest were: 6. Economic outcomes
1. Mental state
1.1 Clinically significant change as defined in individual studies
1.2 Continuous measures of mental state. Search methods for identification of studies
2. Behaviour
2.1 Violent or aggressive behaviour
3. Adverse effects Electronic searches
3.1 Physical adverse effects
1. Electronic searching
3.2 Death, suicide or by other causes
In a first phase relevant randomised trials were identified by search-
3.3 Psychological adverse effects
ing the following two electronic databases:
4. Medication
4.1 Use of antipsychotic medication
1.1 The Cochrane Controlled Trials Register (Issue 1, 1999) was
4.2 Parental administration
searched using the phrase:
4.3 Use of minor tranquilizers
COERCION or COERCIVE* or COMPULSOR* or INVOL-
4.4 Parental administration
UNTA* or RESTRAI* or SECLU* or ((IMMOBILI* or ISOLA-
5. Hospitalization
TION) and (PSYCH* or SCHIZO* or AGGRESSI* or MEN-
5.1 Length of hospital stay
TAL* or MENTAL-DISORDERS*:ME)) or COERCION*:
5.2 Changes in hospital status
ME or COMMITMENT-OF-MENTALLY-ILL*:ME or RE-
6. Satisfaction with care
STRAINT-PHYSICAL*:ME or (PATIENT-ISOLATION*:ME
6.1 Patient satisfaction
not BACTERIAL-INFECTIONS-OR-MYCOSES*:ME).
6.2 Carer satisfaction
1.2 Cochrane Schizophrenia Groups Register (January 1999) was
7. Economic outcomes
searched using the phrase:
Restraint and seclusion are primarily interventions used in re-
COERCION or COERCIVE* or COMPULSOR* or IMMO-
sponse to an urgent need. Outcomes were grouped according to
BILI* or INVOLUNTA* or ISOLATION or RESTRAI* or SE-
time periods: short term (less than one hour), medium term (1-
CLU*
12 hours) and long term (more than 12 hours).
1.3 Biological Abstracts (January 1989 to May 1998) was searched
Prevention of seclusion and restraint
using the Cochrane Schizophrenia Groups phrase for both ran-
The outcome measures used in each trial were described.
domised controlled trials and schizophrenia (see Group search
The primary outcomes of interest were:
strategy) combined with the phrase:
1. Changes in levels of seclusion and restraint.
[and (COERCION or COERCIVE* or COMPULSOR* or IN-
VOLUNTA* or RESTRAI* or SECLU* or (IMMOBILI* or ISO-
LATION))]
Secondary outcomes
1.4 CINAHL (1982 to August 1998) was searched using the
The secondary outcomes of interest were Cochrane Schizophrenia Groups phrase for both randomised con-
1. Changes in symptoms trolled trials and schizophrenia (see Group search strategy) com-
1.1. Violent or aggressive behaviour bined with the phrase:
1.2. Psychiatric symptoms [and (COERCI* or COMPULS* or INVOLUNTA* or RE-
2. Adverse effects STRAI* or SECLU* or ((CONTAIN* or LOCK* or PADDED
2.1. Physical adverse effects near1 ROOM) and (PSYCH*)) or (TIME near1 OUT) or ((SO-
2.1.1. Death, by suicide or other causes CIAL near1 CONTROL) and (FORMAL or INFORMAL)))]
2.2. Psychological adverse effects 1.5 EMbase (January 1980 to November 1998) was searched using
3. Medication the Cochrane Schizophrenia Groups phrase for both randomised
3.1. Use of antipsychotic medication controlled trials and schizophrenia (see Group search strategy)
3.1.1. Parental administration combined with the phrase:
3.2. Use of minor tranquilizers [and (COERCI* or COMPULS* or INVOLUNTA* or SE-
3.2.1. Parental administration CLU* or RESTRAI* or explode INVOLUNTARY-COM-
4. Hospitalization MITMENT/ all subheadings or ((CONTAIN* or LOCK* or
4.1. Length of hospital stay PADDED) near1 ROOM) or (PATIENT near1 ISOLATION)
4.2. Changes in hospital status or (PIN near1 DOWN) or (TIME near1 OUT) or ((SOCIAL
5. Satisfaction with care near1 CONTROL) and (FORMAL or INFORMAL)) or explode
5.1. Patient satisfaction INVOLUNTARY-COMMITMENT/ all subheadings)]

Seclusion and restraint for people with serious mental illnesses (Review) 4
Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
1.6 MEDLINE (January 1966 to May 1998) was searched using
the Cochrane Schizophrenia Groups phrase for both randomised
controlled trials and schizophrenia (see Group search strategy)
combined with the phrase:
[and (COERCI* or COMPULSOR* or (INVOLUNTA* not
MOVEMENT) or SECLU* or (RESTRAI* not ANIMAL) or
explode COERCION(MeSH)/all subheadings or explode COM-
MITMENT-OF-MENTALLY-ILL(MeSH)/all subheadings or
(explode RESTRAINT-PHYSICAL(MeSH)/all subheadings and
HUMAN(MeSH)) or explode PATIENT-ISOLATION(MeSH)/
all subheadings or ((CONTAIN* or LOCK* or PADDED) near1
ROOM) or ((SOCIAL near1 CONTROL) and (FORMAL or
INFORMAL)) or ((PATIENT near1 ISOLATION) and (MEN-
TAL or PSYCH* or AGGRESSI* or SCHIZO*)))]
1.7 MEDIC, a Finnish medical database (1979 to May 1998) was
searched with the phrase:
(CLINICAL TRIALS or RANDOMIS or KONTROLLOI or
SATUNNAISTET or VERTAIL or HOITOKO) and (ERIST or
PAKKO or LEPOSI or COERCION or COMMITMENT or
ISOLATION or RESTRAINT)
1.8 PsycLIT (January 1974 to December 1997) was searched using
the Cochrane Schizophrenia Groups phrase for both randomised
controlled trials and schizophrenia (see Group search strategy)
combined with the phrase:
[and (SECLU* or PATIENT-SECLUSION or (RESTRAI* not
DIET) or PHYSICAL-RESTRAINT or COERCI* or COM-
PULSOR* or (INVOLUNTA* not MOVEMENT) or IN-
VOLUNTARY-TREATMENT or IMMOBILI* or (PATIENT*
near1 SECLU*) or COMMITMENT OF MENTALLY ILL or
PATIENT-ISOLATION)]
1.9 Sociofile (1974 to December 1997) was searched using the
Cochrane Schizophrenia Groups phrase for both randomised con-
trolled trials and schizophrenia (see Group search strategy) com-
bined with the phrase:
[and (SECLU* or RESTRAI* or COERCI* or COMPULSO* or
INVOLUNTA* or IMMOBILI*or(PATIENT* and ISOLAT*))]
1.10 SPRI (a Swedish database for health technology assessment
and
research and development) and SWEMED (a medical database
covering Sweden and Norway) (1982 to May 1998).
(CLINICAL TRIALS(MeSH) or RANDOMIS or KONTROLL-
GRUPP or KONTROLLERAD or BEHANDLINGSSTUDIE)
and (TVNG or TVANG or RUMSRESTRIKTION or FRI-
HETSBERVANDE or *BLTE* or ISOLERING* or COER-
CION or COMMITMENT or ISOLATION or RESTRAINT)
1.11 Social Sciences Citation Index (SSCI) (January 1996 to July
1998) was searched using the phrase:
(RANDOMI* or ((SINGL* or DOUBL* or TREBL* or TRIPL*)
and (BLIND* or MASK*)) or CROSSOVER or TRIAL) and (SE-
CLU* or RESTRAI* or COERCIVE* or COERCION* or COM-
PULSOR* or INVOLUNTA* or IMMOBILI* or PATIENT-
ISOLATION)
Seclusion and restraint for people with serious mental illnesses (Review)
Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
1.12 WILP (Wilson Index to Legal Periodicals) (1983 to May
1998) was searched with the phrase:
COERCIVE* or COERCION or COMPULSOR* or IN-
VOLUNTA* or RESTRAI* or SECLU* or (IMMOBILI* and
(PSYCH* or SCHIZO* or AGGRESSI* or MENTAL*)) or (PA-
TIENT and ISOLATION)
Prevention of seclusion and restraint
2. Electronic searching
In a first phase relevant randomised trials were identified by search-
ing the following two electronic databases:
2.1 THE COCHRANE LIBRARY CENTRAL Issue 4, 1999, was
searched using the phrase:
[explode (Aggression/ all subheadings) or (explode Violence/
all subheadings) or (Dangerous-Behavior) or violen* or aggressi*
or attack* or assault* or agita* or ((danger* or bizarre) near (behav*
or action* or conduct*))]
2.2 COCHRANE SCHIZOPHRENIA GROUPS REGISTER
(October 1999) was searched using the phrase:
[violen* or aggressi* or attack* or assault* or agita* or ((danger*
or bizarre) and (behav* or action* or conduct*))]
Conference abstracts were sought from within the Cochrane
Schizophrenia Groups Register. After the trials were selected and
the review was ongoing, other databases were investigated:
2.3 BIOLOGICAL ABSTRACTS/RRM (January 1989 to Au-
gust 1999) was searched using the both phrases used to identify
randomised controlled trials and articles relating to schizophrenia
as published in the Cochrane Schizophrenia Groups search strat-
egy combined with the phrase:
AND [violen* or aggressi* or attack* or assault* or agita* or ((dan-
ger* or bizarre) near (behav* or action* or conduct*))]
2.4 CINAHL (1982 to August 1999) was searched using the both
phrases used to identify randomised controlled trials and articles
relating to schizophrenia as published in the Cochrane Schizophre-
nia Groups search strategy combined with the phrase:
AND [(explode Aggression/ all topical subheadings/ all age sub-
headings) or violen* or aggressi* or attack* or assault* or agita* or
((danger* or bizarre) near (behav* or action* or conduct*))]
2.5 EMBASE (January 1980 to August 1999) was searched using
the both phrases used to identify randomised controlled trials and
articles relating to schizophrenia as published in the Cochrane
Schizophrenia Groups search strategy combined with the phrase:
AND [(explode Aggression/ all subheadings) or (explode Vio-
lence/ all subheadings) or violen* or aggressi* or attack* or as-
sault* or agita* or ((danger* or bizarre) near (behav* or action* or
conduct*))]
2.6 MEDLINE (January 1966 to May 1999) was searched using
the both phrases used to identify randomised controlled trials and
articles relating to schizophrenia as published in the Cochrane
Schizophrenia Groups search strategy combined with the phrase:
AND [(explode Aggression/ all subheadings) or (explode Vio-
lence/ all subheadings) or (Dangerous-Behavior) or violen* or
aggressi* or attack* or assault* or agita* or ((danger* or bizarre)
5
near (behav* or action* or conduct*))]
2.7 PSYCLIT (January 1974 to May 1999) was searched using
the both phrases used to identify randomised controlled trials and
articles relating to schizophrenia as published in the Cochrane
Schizophrenia Groups search strategy combined with the phrase:
AND [(explode Aggression) or (explode Violence) or (Dan-
gerousness-in DE) or violen* or aggressi* or attack* or assault*
or agita* or ((danger* or bizarre) near (behav* or action* or con-
duct*))]
2.8 SOCIOFILE (1974 to May 1999) was searched using the
phrase used to identify articles relating to schizophrenia as pub-
lished in the Cochrane Schizophrenia Groups search strategy com-
bined with the phrase:
(RANDOMI* or ((SINGL* or DOUBL* or TREBL* or TRIPL*)
and (BLIND* or MASK*)) or CROSSOVER or TRIAL) and
(AGGRESSI* or VIOLEN* or AGITA* or ((DANGER* or
BIZARRE*) and BEHAV*)
2.9 Social Sciences Citation Index (SSCI) (Jan 1996 to Jul 1999)
was searched using the phrase used to identify articles relating to
schizophrenia as published in the Cochrane Schizophrenia Groups
search strategy combined with the phrase:
(RANDOMI* or ((SINGL* or DOUBL* or TREBL* or TRIPL*)
and (BLIND* or MASK*)) or CROSSOVER or TRIAL) and
(AGGRESSI* or VIOLEN* or AGITA* or ((DANGER* or
BIZARRE*) and BEHAV*)
3. Cochrane Schizophrenia Groups Trials Register (May 2012)
We updated this search 10 May 2012. The Trials Search Co-ordi-
nator searched the Cochrane Schizophrenia Groups Trials Regis-
ter.
The Cochrane Schizophrenia Groups Trials Register is compiled
by systematic searches of major databases, handsearches and con-
ference proceedings (see group module).
Trials identified through the searching activities are each assigned
to awaiting classification of relevant review titles.
Searching other resources
1. Reference searching
The references of all identified studies were also inspected for more
trials. Science Citation Index (SCI) and Social Sciences Citation
Index (SSCI) (1974 to May 1999) was used to trace papers that
had cited included trials. These reports were inspected in order
to identify further trials. SciSearch and Social SciSearch (1974 to
May 1998) were to be used to trace papers that had cited included
trials. These reports were to be inspected in order to identify further
trials.
2. Personal contact
The first author of each included study was contacted for infor-
mation regarding unpublished trials.
Seclusion and restraint for people with serious mental illnesses (Review)
Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Data collection and analysis
[For definitions of terms used in this, and other sections, please
refer to The Cochrane Library Glossary.]
1. Selection of trials for the review
The title and abstract of each reference identified by the search was
inspected independently by both reviewers to assess its relevance.
Where disagreement between the two reviewers occurred, the full
article was obtained. Relevance was again assessed independently
by both reviewers. Again, where disagreement occurred this was
resolved by discussion and when this was not possible, further
information was sought. These trials were added to the list of those
awaiting assessment pending acquisition of further information.
2. Assessment of the methodological quality of the included trials.
The criteria included in the Cochrane Collaboration Handbook
(Mulrow 1999) was used to assess the quality of the trials. It is based
on the evidence of a strong relationship between the potential for
bias in results and the concealment of allocation and is defined as
below:
A. Low risk of bias (adequate allocation concealment);
B. Moderate risk of bias (some doubt about the results);
C. High risk of bias (inadequate allocation concealment).
Trials were included if they met the criteria A or B on this quality
criteria.
The Jadad Scale (Jadad 1996) was used to give a second quality
rating to the relevant trials.
3. Data collection
Data from selected trials were independently extracted by both
reviewers. When disputes arose, resolution was attempted by dis-
cussion. When this was not possible and further information was
necessary to resolve the disagreement, the decisions documented
and where necessary, the authors of the studies were contacted for
clarification. Justification for excluding references from the review
was documented.
4. Data synthesis
4.1 Incomplete data.
With the exception of the outcome of leaving the study early, trial
outcomes were not included if more than 40% of people were not
reported in the final analysis.
4.2 Dichotomous - yes/no - data.
As long as over 60% of people completed the study, everyone
allocated to the intervention was counted, whether they completed
the follow up or not. It was assumed that those who dropped out
had the negative outcome, with the exception of death.
Relative risk (RR) and 95% confidence interval (CI) were calcu-
lated. If outcomes were heterogeneous calculations were based on
the random effects model, as it takes into account any differences
between studies. If outcomes were homogeneous, a fixed effects
model was applied. Data were inspected to see if analysis using
a Mantel Haenszel odds ratio made any substantive difference.
Where possible, number needed to treat (NNT) was estimated
from the weighted pooled relative risk estimate.
4.3 Continuous data.
6
4.3.1 Rating scales: A wide range of instruments are available to
measure mental health outcomes. These instruments vary in qual-
ity and many are not valid, or even ad hoc. For outcome instru-
ments minimum standards were set. They were that the psycho-
metric properties of the instrument should have been described in
a peer-reviewed journal.
4.3.2 Normal data: Mental health continuous data is often not
normally distributed. To avoid the pitfall of applying parametric
tests to non-parametric data the following standards were applied
to all data before inclusion:
i. standard deviations and means were reported in the paper or
were obtainable from the authors;
ii. if the data were scale-derived, or finite measures from, for ex-
ample 0-100, the standard deviation was multiplied by two. If the
result was less than the mean (as otherwise the mean was unlikely
to be an appropriate measure of the centre of the distribution
(Altman 1996) data were included in meta-analysis and presented
in graphical form.
Data not meeting these standards were reported in the Other
data types of the Results section if they had been analysed with
appropriate non-parametric tests.
5. Heterogeneity
Heterogeneity in the results of the trials was assessed both by in-
spection of graphical presentations and by calculating a chi-square
test of heterogeneity. If heterogeneity was present any underlying
explanation was sought.
The reviewers undertook a sensitivity analysis to the presence or
absence of these data. All data from studies that have been selected
were presented.
6. Addressing publication bias
Data from all identified and selected trials were entered into a fun-
nel graph (trial effect versus trial size) in an attempt to investigate
the likelihood of overt publication bias.
7. Tables and figures
Where possible data were entered into RevMan in such a way that
the area to the left of the line of no effect indicates a favourable
outcome for the intervention of interest.
RESULTS
Description of studies
See: Characteristics of excluded studies; Characteristics of studies
awaiting classification.
1. Effects of seclusion and restraint
Excluded studies
All 24 identified studies were excluded. For the full description
of why these studies were not included, please see the Excluded
studies table. Most did not meet minimum inclusion criteria for
Seclusion and restraint for people with serious mental illnesses (Review)
Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
their methods, participants or interventions of interest. Most fo-
cused upon the restraint of elderly and confused people and on
preventing wandering or falling.
Ten studies focused on restraining elderly people with either or-
ganic problems or physical ill health. Another was a preliminary
report of a trial of room design to aid confused, physically ill peo-
ple and a further two, investigating the value of restraining elderly
confused people, did not use a control.
Four trials did not focus on interventions of interest - either ad-
equate medication or psychosocial environments. A single ran-
domised experiment focused on staff attitudes to using electric
shocks of people before and after watching a video of a violent
person and another investigated the value of different restraint
techniques on healthy volunteers. One randomised trial of a single
person investigated the value of different protective clothing on
a 13-year-old adolescent with profound learning difficulties, and
finally, four were surveys.
2. Prevention of seclusion and restraint
Work underway.
3. Studies awaiting classification
There are 2 studies awaiting classification (Bergk 2011;
ISRCTN49454276).
Risk of bias in included studies
1. Effects of seclusion and restraint
No trials were able to be included.
2. Prevention of seclusion and restraint
Work underway.
Effects of interventions
1. Effects of seclusion and restraint
Search
The search strategy yielded 2155 citations. The Cochrane Con-
trolled Trials Register yielded 1018 citations, the Cochrane
Schizophrenia Groups Register 126, Biological Abstracts 207,
CINAHL 48, EMbase 360, MEDIC zero, MEDLINE 123, Psy-
cLIT 215, Sociofile 27, SPRI & SWEMED one, SSCI 70 and
WILP zero. Of these, the full articles for 35 studies were obtained.
These same articles came up in several databases (The Cochrane
Library CENTRAL, MEDLINE, CINAHL and PsycLIT). From
these citations, 18 studies for potential inclusion were identified.
No relevant additional studies were found by searching the refer-
ences of excluded studies.
Lack of data
No studies using restraint or seclusion as an intervention measure
in the treatment of psychiatric emergencies were found, but four
studies had seclusion or restraint as an outcome. Not one paper
fulfilled the pre-stated criteria of the reviewers. As has been dis-
cussed above, most studies focused on restraining elderly people
7
with psycho-organic problems or physical ill health in order to
prevent them from falling or wandering. There is a surprising and
shocking lack of published trials assessing the effects of secluding
or restraining people with schizophrenia or similar psychotic ill-
nesses.
2. Prevention of seclusion and restraint
Work underway.
DISCUSSION
The reviewers acknowledge the very great difficulty of carrying out
controlled trials in people with challenging behaviours. Neverthe-
less, the complete lack of trial-derived evidence regarding the ef-
fects of seclusion and restraint is surprising given the invasiveness
of the intervention and its continued use over time. This dearth
may highlight a belief that they are such effective, satisfactory in-
terventions that there is not the need for evaluation in randomised
trials. Counter to this is that certain researchers, not satisfied with
the effects or nature of seclusion and restraint, have attempted to
find creative alternatives (Nijman 1997).
Randomising different techniques of seclusion and restraint, or
comparing the former to alternatives, may be thought to be con-
troversial. Conversely, continuing to use a poorly investigated set
of invasive treatments on very significant numbers of people (Way
1990) may seem equally questionable.
Three studies were found that reported an improvement in con-
trol of aggression with adequate medication (Chow 1996, Essock
1996, Sommerness 1957). Another trial used a psychosocial pro-
gramme to reduce the number of episodes of seclusion (Gudeman
1981). These trials are not included in the review of effects of
seclusion and restraint as they were not the primary interventions
of interest. These will be included in the amended review, includ-
ing also interventions aimed at reducing need for seclusion and
restraint in those with serious mental illness.
AUTHORS CONCLUSIONS
Implications for practice
In the absence of any controlled trials in those with serious mental
illness, no recommendation can be made about the effectiveness,
benefit or harmfulness of seclusion or restraint. In view of data
from non-randomised studies, use should be minimised for ethical
reasons. The use of seclusion or restraint should only be contin-
ued in the context of simple, pragmatic randomised trials given
Seclusion and restraint for people with serious mental illnesses (Review)
Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
the marked variation between institutions and reports of harm in
qualitative reviews.
No controlled studies to support the continued use of seclusion
or restraint in clinical practice were found. As there are reports
of serious adverse effects reported in qualitative reviews (Fisher
1994), randomised controlled trials are needed to test the benefits
and harms of seclusion and restraint. Attempts must be made to
find alternative methods of dealing with unwanted behaviours.
For those with serious mental illness and their relatives
No evidence exists to support or refute the use of these interven-
tions. Although seclusion and restraint techniques are undoubt-
edly unpleasant, as strategies for preventing assault to others or
harm to oneself, these containing treatments may still be both
practical and safe. On the other hand, the use of seclusion and
restraint could lead to greater morbidity and mortality than alter-
native drug or non-drug approaches. Those with serious mental
illness and their relatives could well pre-specify which technique
they would find preferable should their mental state or behaviour
seriously deteriorate.
For practitioners
In the absence of any relevant controlled trials, no trial-based rec-
ommendations can be made about the effects of seclusion or re-
straint. In view of data from non-randomised studies, use should
be minimised for ethical reasons (Fisher 1994). It is arguable that,
except for extreme circumstances, the use of seclusion or restraint
should only be continued in the context of simple, pragmatic ran-
domised trials.
Implications for research
Seclusion and restraint are used in the hope of preventing injury
and reducing agitation, but qualitative studies have reported sub-
stantial deleterious physical, and, more often, psychological ef-
fects on both patients and staff (Fisher 1994). Randomised stud-
ies are urgently needed. These could compare seclusion and re-
straint and other interventions such as adequate medication, al-
ternative environments, psychosocial interventions or staff edu-
cation. Randomised trials should be well planned, executed and
reported. Randomising people recognisable in routine practice to
generalisable interventions, and measuring simple, clinically rele-
vant outcomes would greatly increase the value of these trials.
ACKNOWLEDGEMENTS
The reviewers would like to thank Kristian Wahlbeck for his edi-
torial comments.
8
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Evans 1997 {published data only}
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(7):7916. [MEDLINE: 1997358207]
Foxx 1996 {published data only}
Foxx RM, McHenry IWC, Bremer BA. The effects of
a video vignette on increasing treatment acceptability.
Behavioral Interventions 1996;11:13140.
Frank 1996 {published data only}
Frank C, Hodgetts G, Puxty J. Safety and efficacy of
physical restraints for the elderly. Review of the evidence.
Canadian Family Physician 1996;42:24029. [MEDLINE:
1997124722]
Gaebler 1994 {published data only}
Gaebler S. Just who do we restrain?. Australian Nursing
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Glazer 1998 {published data only}
Glazer WM, Dickson RA. Clozapine reduces violence
and persistent aggression in schizophrenia. Journal of
Clinical Psychiatry 1998;59(Suppl 3):814. [MEDLINE:
1998200403]
Janelli 1997 {published data only}
Janelli LM, Kanski GW. Music intervention with
physically restrained patients. Rehabilitation Nursing 1997;
22(1):149. [MEDLINE: 1997265052]
Lewis 1996 {published data only}
Lewis MH, Bodfish JW, Powell SB, Parker DE, Golden
RN. Clomipramine treatment for self-injurious-behavior
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Mental Retardation 1996;100(6):65465. [MEDLINE:
1996328507]
Moretz 1995 {published data only}
Moretz C, Dommel A, Deluca K. Untied: a safe
alternative to restraints. Medsurg Nursing 1995;4(2):
12832. [MEDLINE: 1995227262]
Nijman 1997 {published data only}
Nijman HL, Merckelbach HL, Allertz WF, a Campo JM.
Prevention of aggressive incidents on a closed psychiatric
ward. Psychiatric Services 1997;48(5):6948. [MEDLINE:
1997290041]
Phillips 1995 {published data only}
Phillips D, Rudestam KE. Effect of nonviolent self-defense
training on male psychiatric staff members aggression and
fear. Psychiatric Services 1995;46(2):1648. [MEDLINE:
1995227782]
Roeggla 1997 {published data only}
Roeggla M, Wagner A, Muellner M, Bur A, Roeggla H,
Hirschl MM, Laggner AN, Roeggla G. Cardiorespiratory
consequences to hobble restraint. Wiener Klinische
Wochenschrift 1997;109(10):35961. [MEDLINE:
1997344350]
Rovner 1996 {published data only}
Rovner BW, Steele CD, Shmuely Y, Folstein MF. A
randomized trial of dementia care in nursing homes.
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[MEDLINE: 1996136183]
Schnelle 1992 {published data only}
Schnelle JF, Newman DR, White M, Volner TR, Burnett
J, Cronqvist A, Ory M. Reducing and managing restraints in
long-term-care facilities. Journal of the American Geriatrics
Society 1992;40(4):3815. [MEDLINE: 1992210972]
Schnelle 1996 {published data only}
Schnelle JF, MacRae PG, Giacobassi K, MacRae HS,
Simmons SF, Ouslander JG. Exercise with physically
restrained nursing home residents: maximizing benefits of
restraint reduction. Journal of the American Geriatrics Society
1996;44(5):50712. [MEDLINE: 1996208900]
Silverman 1984 {published data only}
Silverman K, Watanabe K, Marshall AM, Baer DM.
Reducing self-injury and corresponding self-restraint
through the strategic use of protective clothing. Journal of
Applied Behavior Analysis 1984;17(4):54552. [MEDLINE:
1985130685]
Stoudemire 1996 {published data only}
Stoudemire A, Smith DA. OBRA regulations and the use
of psychotropic drugs in long term care facilities - impact
and implications for geropsychiatric care. General Hospital
Psychiatry 1996;18(2):7794. [MEDLINE: 1996430451]
Thapa 1996 {published data only}
Thapa PB, Brockman KG, Gideon P, Fought RL, Ray WA.
Injurious falls in nonambulatory nursing home residents -
a comparative study of circumstances, incidence, and risk
factors. Journal of the American Geriatrics Society 1996;44
(3):2738. [MEDLINE: 1996184683]
Thomas 1992 {published data only}
Thomas H Jr, Schwartz E, Petrilli R. Droperidol versus
haloperidol for chemical restraint of agitated and combative
patients. Annals of Emergency Medicine 1992;21(4):40713.
[MEDLINE: 1992206716]
Tutunjian 1963 {published data only}
Tutunjian K, Guido JA. A new piperidine phenothiazine
(pereracetazine) in chronic psychotic patients. American
Journal of Psychiatry 1963;119:7767.
Weinrich 1995 {published data only}
Weinrich S, Egbert C, Eleazer GP, Haddock KS.
Agitation: measurement, management, and intervention
research. Archives of Psychiatric Nursing 1995;9(5):25160.
[MEDLINE: 1996031176]
References to studies awaiting assessment
Bergk 2011 {published data only}
Bergk J, Einsiedler B, Flammer E, Steinert T. A randomized
controlled comparison of seclusion and mechanical restraint
in inpatient settings. Psychiatric Services 2011;62(11):
13107. [MEDLINE: 22211210]
ISRCTN49454276 {published data only}
Huf G, Coutinho ES, Adams CE. Physical restraints
versus seclusion room for management of people with
acute aggression or agitation due to psychotic illness
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(trec-save): A randomized trial. Psychological Medicine
2012 Mar 12 [Epub ahead of print]. [DOI: 10.1017/
S0033291712000372; MEDLINE: 22405443]
Huf G, Coutinho ES, Ferreira MA, Ferreira S, Mello F,
Adams CE. Trec-save: A randomised trial comparing
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or violent seriously mentally ill people: Study protocol
for a randomised controlled trial. Trials 2011;12(1):180.
[MEDLINE: 21774823]
Huf G, Coutinho ESF. TREC-SAVE1.A randomised trial
comparing mechanical restraints with use of seclusion for
aggressive or violent seriously mentally ill people. Data on
file.
ISRCTN49454276. Trec-save: A trial for aggressive or
violent seriously mentally ill people. http://www.controlled-
trials.com 2011.
Additional references
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Angold 1989
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APA 1985
American Psychiatric Association. Seclusion and restraint:
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American Psychiatric Association, 1985.
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Aschen SR. Restraints: does position make a difference?
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Brown JS, Tooke SK. On the seclusion of psychiatric
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Crenshaw 1997
Crenshaw WB, Cain KA, Francis PS. An updated national
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Essock 1996
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10
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Fisher WA. Restraint and seclusion: a review of the
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Gerlock 1983
Gerlock A, Solomon HC. Factors associated with the
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Gudeman 1981
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Jadad A, Moore A, Carroll D, Jenkinson C, Reynolds
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Kalogjera IJ, Ashok B, Watson WN, Meyer AD. Impact
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Salib E, Ahmed AG, Cope M. Practise of seclusion: a five-
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Walsh E, Randell B. Seclusion and restraint: what do we
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Way BB, Banks SM. Use of seclusion and restraint in public
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Indicates the major publication for the study
11
CHARACTERISTICS OF STUDIES

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Alessi 1995 Alllocation: randomised.

Participants: elderly (mean age 85 years), mainly problems of urinary incontinence or physically restrained to
prevent wandering or falls.
Interventions: physical exercise every two hours versus once a day

Buckley 1997 Allocation: not randomised.

Intervention: risperidone.

Clark 1995 Allocation: randomised.

Participants: >65 yrs, confused, diagnosis of acute physical illness.
Interventions: Dayroom care versus usual care.

Cole 1994 Allocation: randomised.

Participants: aged over 75 with delirium (DSM III).
Interventions: consultation with geriatric internist and follow up by liaison nurse versus standard medical care

Collard 1985 Allocation: randomised.

Participants: mean age >77 years, primarily with physical illness.
Interventions: care in geriatric intensive care unit versus traditional ward

Evans 1997 Allocation: randomised elderly care homes.

Participants: Age over 80, cognitively impaired.
Interventions: restraint education versus restraint education and consultation versus no education or consultation

Foxx 1996 Allocation: randomised.

Participants: staff associated with programs serving persons with developmental disabilities.
Intervention: video of a violent person versus no video.

Frank 1996 Allocation: not randomised, review article.

Gaebler 1994 Allocation: not randomised, survey of incidence of restraint in the elderly

Glazer 1998 Allocation: not randomised, survey of aggressive incidents in trials of clozapine

Janelli 1997 Allocation: not randomised, case control.

Participants: elderly people restrained to prevent falls or wandering
Intervention: music through headphones versus no music.

Lewis 1996 Allocation: randomised.

Participants: people with severe and profound mental retardation.
Interventions: clomipramine versus placebo.

Seclusion and restraint for people with serious mental illnesses (Review) 12
Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)

Moretz 1995 Allocation: unclear, preliminary report.

Participants: over 70 years old, mentally impaired.
Intervention: restraint free room, no obvious control.

Nijman 1997 Allocation: not randomised.

Participants: those admitted to a locked unit.
Interventions: protocol for talking to participants who were displaying aggressive behaviour, discussing treatment
goals, explaining why the ward door was locked, providing a shedule of staff mettings, and clarifying the procedure
for making an appointment with the psychiatrist
This was the one of the few studies that made a comprehensive attempt to try and find alternative psychosocial
treatments to seclusion or restraint

Phillips 1995 Allocation: randomised.

Participants: self-selected male mental health staff.
Interventions: didactic training of staff versus didactic training and physical skills versus no training

Roeggla 1997 Allocation: randomised, cross-over trial.

Participants: healthy male volunteers.
Interventions: prone versus upright hobble restraint.

Rovner 1996 Allocation: randomised.

Participants: mean age > 81 years, dementia.
Interventions: a dementia care program versus usual care.

Schnelle 1992 Allocation: randomised.

Participants: mean age 84 years, severely impaired physically and cognitively.
Interventions: coloured pads used to indicate the patient had been released from restraint every two hours versus
no pads

Schnelle 1996 Allocation: randomised.

Participants: mean age 84 years, participants needed to know their own name or be able to name one of two
objects (pen or comb) to be included.
Intervention: walking or whell-chair movement and rowing exercise versus usual care

Silverman 1984 Allocation: randomised, crossover, N of 1.

Participants: one 13 year old profoudly retarded person.
Interventions: padded helmet versus padded helmet and padded slippers versus no protective clothing

Stoudemire 1996 Allocation: not randomised, review.

Thapa 1996 Allocation: not randomised, prevalence survey of injurious falls, prospective cohort study

Thomas 1992 Allocation: randomised.

Participants: violent patients, admitted to emergency department, physically ill mostly with trauma.
Interventions: IM haloperidol or droperidol versus IV haloperidol or droperidol

Seclusion and restraint for people with serious mental illnesses (Review) 13
Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)

Tutunjian 1963 Allocation: not randomised, case series.

Participants: psychotic female patients.
Intervention: peperacetazine, no control.

Weinrich 1995 Allocation: not randomised, review of managing agitation.

Characteristics of studies awaiting assessment [ordered by study ID]

Bergk 2011

Methods

Participants

Interventions

Outcomes

Notes To be assessed.

ISRCTN49454276

Methods

Participants

Interventions

Outcomes

Notes To be assessed.

Seclusion and restraint for people with serious mental illnesses (Review) 14
Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DATA AND ANALYSES
This review has no analyses.

APPENDICES

Appendix 1. Previous searches

1. Electronic searching
In a first phase relevant randomised trials were identified by searching the following two electronic databases:

1.1 The Cochrane Controlled Trials Register (Issue 1, 1999) was searched using the phrase:
COERCION or COERCIVE* or COMPULSOR* or INVOLUNTA* or RESTRAI* or SECLU* or ((IMMOBILI* or ISOLATION)
and (PSYCH* or SCHIZO* or AGGRESSI* or MENTAL* or MENTAL-DISORDERS*:ME)) or COERCION*:ME or COM-
MITMENT-OF-MENTALLY-ILL*:ME or RESTRAINT-PHYSICAL*:ME or (PATIENT-ISOLATION*:ME not BACTERIAL-
INFECTIONS-OR-MYCOSES*:ME).
1.2 Cochrane Schizophrenia Groups Register (January 1999) was searched using the phrase:
COERCION or COERCIVE* or COMPULSOR* or IMMOBILI* or INVOLUNTA* or ISOLATION or RESTRAI* or SECLU*
1.3 Biological Abstracts (January 1989 to May 1998) was searched using the Cochrane Schizophrenia Groups phrase for both randomised
controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (COERCION or COERCIVE* or COMPULSOR* or INVOLUNTA* or RESTRAI* or SECLU* or (IMMOBILI* or ISOLA-
TION))]
1.4 CINAHL (1982 to August 1998) was searched using the Cochrane Schizophrenia Groups phrase for both randomised controlled
trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (COERCI* or COMPULS* or INVOLUNTA* or RESTRAI* or SECLU* or ((CONTAIN* or LOCK* or PADDED near1
ROOM) and (PSYCH*)) or (TIME near1 OUT) or ((SOCIAL near1 CONTROL) and (FORMAL or INFORMAL)))]
1.5 EMbase (January 1980 to November 1998) was searched using the Cochrane Schizophrenia Groups phrase for both randomised
controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (COERCI* or COMPULS* or INVOLUNTA* or SECLU* or RESTRAI* or explode INVOLUNTARY-COMMITMENT/
all subheadings or ((CONTAIN* or LOCK* or PADDED) near1 ROOM) or (PATIENT near1 ISOLATION) or (PIN near1 DOWN)
or (TIME near1 OUT) or ((SOCIAL near1 CONTROL) and (FORMAL or INFORMAL)) or explode INVOLUNTARY-COM-
MITMENT/ all subheadings)]
1.6 MEDLINE (January 1966 to May 1998) was searched using the Cochrane Schizophrenia Groups phrase for both randomised
controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (COERCI* or COMPULSOR* or (INVOLUNTA* not MOVEMENT) or SECLU* or (RESTRAI* not ANIMAL) or explode
COERCION(MeSH)/all subheadings or explode COMMITMENT-OF-MENTALLY-ILL(MeSH)/all subheadings or (explode RE-
STRAINT-PHYSICAL(MeSH)/all subheadings and HUMAN(MeSH)) or explode PATIENT-ISOLATION(MeSH)/all subheadings
or ((CONTAIN* or LOCK* or PADDED) near1 ROOM) or ((SOCIAL near1 CONTROL) and (FORMAL or INFORMAL)) or
((PATIENT near1 ISOLATION) and (MENTAL or PSYCH* or AGGRESSI* or SCHIZO*)))]
1.7 MEDIC, a Finnish medical database (1979 to May 1998) was searched with the phrase:
(CLINICAL TRIALS or RANDOMIS or KONTROLLOI or SATUNNAISTET or VERTAIL or HOITOKO) and (ERIST or
PAKKO or LEPOSI or COERCION or COMMITMENT or ISOLATION or RESTRAINT)
1.8 PsycLIT (January 1974 to December 1997) was searched using the Cochrane Schizophrenia Groups phrase for both randomised
controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (SECLU* or PATIENT-SECLUSION or (RESTRAI* not DIET) or PHYSICAL-RESTRAINT or COERCI* or COM-
PULSOR* or (INVOLUNTA* not MOVEMENT) or INVOLUNTARY-TREATMENT or IMMOBILI* or (PATIENT* near1
SECLU*) or COMMITMENT OF MENTALLY ILL or PATIENT-ISOLATION)]
1.9 Sociofile (1974 to December 1997) was searched using the Cochrane Schizophrenia Groups phrase for both randomised controlled
trials and schizophrenia (see Group search strategy) combined with the phrase:
Seclusion and restraint for people with serious mental illnesses (Review) 15
Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[and (SECLU* or RESTRAI* or COERCI* or COMPULSO* or INVOLUNTA* or IMMOBILI*or(PATIENT* and ISOLAT*))]
1.10 SPRI (a Swedish database for health technology assessment and
research and development) and SWEMED (a medical database covering Sweden and Norway) (1982 to May 1998).
(CLINICAL TRIALS(MeSH) or RANDOMIS or KONTROLLGRUPP or KONTROLLERAD or BEHANDLINGSSTUDIE) and
(TVNG or TVANG or RUMSRESTRIKTION or FRIHETSBERVANDE or *BLTE* or ISOLERING* or COERCION or
COMMITMENT or ISOLATION or RESTRAINT)
1.11 Social Sciences Citation Index (SSCI) (January 1996 to July 1998) was searched using the phrase:
(RANDOMI* or ((SINGL* or DOUBL* or TREBL* or TRIPL*) and (BLIND* or MASK*)) or CROSSOVER or TRIAL) and
(SECLU* or RESTRAI* or COERCIVE* or COERCION* or COMPULSOR* or INVOLUNTA* or IMMOBILI* or PATIENT-
ISOLATION)
1.12 WILP (Wilson Index to Legal Periodicals) (1983 to May 1998) was searched with the phrase:
COERCIVE* or COERCION or COMPULSOR* or INVOLUNTA* or RESTRAI* or SECLU* or (IMMOBILI* and (PSYCH* or
SCHIZO* or AGGRESSI* or MENTAL*)) or (PATIENT and ISOLATION)
Prevention of seclusion and restraint
2. Electronic searching
In a first phase relevant randomised trials were identified by searching the following two electronic databases:
2.1 THE COCHRANE LIBRARY CENTRAL Issue 4, 1999, was searched using the phrase:
[explode (Aggression/ all subheadings) or (explode Violence/ all subheadings) or (Dangerous-Behavior) or violen* or aggressi* or
attack* or assault* or agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.2 COCHRANE SCHIZOPHRENIA GROUPS REGISTER (October 1999) was searched using the phrase:
[violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) and (behav* or action* or conduct*))]
Conference abstracts were sought from within the Cochrane Schizophrenia Groups Register. After the trials were selected and the review
was ongoing, other databases were investigated:
2.3 BIOLOGICAL ABSTRACTS/RRM (January 1989 to August 1999) was searched using the both phrases used to identify ran-
domised controlled trials and articles relating to schizophrenia as published in the Cochrane Schizophrenia Groups search strategy
combined with the phrase:
AND [violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.4 CINAHL (1982 to August 1999) was searched using the both phrases used to identify randomised controlled trials and articles
relating to schizophrenia as published in the Cochrane Schizophrenia Groups search strategy combined with the phrase:
AND [(explode Aggression/ all topical subheadings/ all age subheadings) or violen* or aggressi* or attack* or assault* or agita* or
((danger* or bizarre) near (behav* or action* or conduct*))]
2.5 EMBASE (January 1980 to August 1999) was searched using the both phrases used to identify randomised controlled trials and
articles relating to schizophrenia as published in the Cochrane Schizophrenia Groups search strategy combined with the phrase:
AND [(explode Aggression/ all subheadings) or (explode Violence/ all subheadings) or violen* or aggressi* or attack* or assault* or
agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.6 MEDLINE (January 1966 to May 1999) was searched using the both phrases used to identify randomised controlled trials and
articles relating to schizophrenia as published in the Cochrane Schizophrenia Groups search strategy combined with the phrase:
AND [(explode Aggression/ all subheadings) or (explode Violence/ all subheadings) or (Dangerous-Behavior) or violen* or
aggressi* or attack* or assault* or agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.7 PSYCLIT (January 1974 to May 1999) was searched using the both phrases used to identify randomised controlled trials and
articles relating to schizophrenia as published in the Cochrane Schizophrenia Groups search strategy combined with the phrase:
AND [(explode Aggression) or (explode Violence) or (Dangerousness-in DE) or violen* or aggressi* or attack* or assault* or
agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.8 SOCIOFILE (1974 to May 1999) was searched using the phrase used to identify articles relating to schizophrenia as published in
the Cochrane Schizophrenia Groups search strategy combined with the phrase:
(RANDOMI* or ((SINGL* or DOUBL* or TREBL* or TRIPL*) and (BLIND* or MASK*)) or CROSSOVER or TRIAL) and
(AGGRESSI* or VIOLEN* or AGITA* or ((DANGER* or BIZARRE*) and BEHAV*)
2.9 Social Sciences Citation Index (SSCI) (Jan 1996 to Jul 1999) was searched using the phrase used to identify articles relating to
schizophrenia as published in the Cochrane Schizophrenia Groups search strategy combined with the phrase:

(RANDOMI* or ((SINGL* or DOUBL* or TREBL* or TRIPL*) and (BLIND* or MASK*)) or CROSSOVER or TRIAL) and
(AGGRESSI* or VIOLEN* or AGITA* or ((DANGER* or BIZARRE*) and BEHAV*)

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Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
WHATS NEW
Last assessed as up-to-date: 26 October 1999.

Date Event Description

10 May 2012 Amended Update search of Cochrane Schizophrenia Groups Trial Register (see Search methods for identification
of studies), 2 studies (Bergk 2011; ISRCTN49454276) added to awaiting classifciation.

HISTORY
Protocol first published: Issue 3, 1998
Review first published: Issue 2, 1999

Date Event Description

31 October 2008 Amended Converted to new review format.

CONTRIBUTIONS OF AUTHORS
Eila Sailas - initiated the review, prepared protocol, undertook searches, selected and acquired studies, produced report.
Mark Fenton - prepared protocol, undertook searches, selected and acquired studies, produced report.

DECLARATIONS OF INTEREST
The reviewers believe that seclusion and restraint can be used to excess and that the least restrictive principle is often not sought.

SOURCES OF SUPPORT

Internal sources
Department of Psychiatry, University of Helsinki, Finland.
Cochrane Schizophrneia Group, UK.

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Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
External sources
Wilhelm and Else Stockmann Foundation, Finland.
STAKES/FinOHTA, Finland.

NOTES
Cochrane Schizophrenia Group internal peer review complete (see Module).
External peer review scheduled.

INDEX TERMS

Medical Subject Headings (MeSH)

Patient Isolation; Restraint, Physical; Antipsychotic Agents [therapeutic use]; Mental Disorders [drug therapy; therapy]

MeSH check words

Humans

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Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.